IRB #

IRB00009571

Title

A Phase II, Randomized Trial of Standard of Care with or without Midostaurin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD Mutated Acute Myeloid Leukemia

Principal Investigator

Richard Maziarz

Study Purpose

The purpose of this trial is to compare the effectiveness of the study drug, midostaurin vs. Standard of Care (SoC) therapy in preventing relapse after donor stem cell transplant in AML patients who have the FLT3-ITD mutation.

Standard of Care means the medications or treatment that would be prescribed by a doctor to treat disease even if a patient were are not participating in this clinical trial.

The study will randomize participants to one of two treatment arms below. Participants have an equal chance of being assigned to either group (like flipping a coin):
• Group 1 will receive: Standard of Care (SOC) treatment alone
• Group 2 will receive: Standard of Care (SOC) treatment plus (+) the study drug (called midostaurin or PKC412)

Medical Condition(s)

FLT3-ITD mutation-positive Acute Myeloid Leukemia

Eligibility Criteria

Patients must:
-Be between 18 and 60 years of age.
-Have AML with the FLT3-ITD mutation as determined by the investigator.
-Have received an allogeneic (donor) stem cell transplant in first complete remission.
-Have not had a prior stem cell transplant.
-Meet health and other criteria as determined by the investigator.

Age Range

18 - 60

Healthy Volunteers Needed

No

Duration of Participation

Participants will be in the treatment phase (receiving either the study drug or SoC therapy alone, depending on what group s/he is placed in) for about 12 months, and will need to come to OHSU monthly for study visits during that time. After the treatment phase, participants will be in the follow-up phase for another 10-12 months and will have study visits every 2 months. If at this time (about 24 months from the date of transplant) the subject has not relapsed or withdrawn from the study, we will ask subjects to return for blood tests every 3 months until the study ends.